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Pharma-shortage! #532029
08/28/18 04:06 AM
08/28/18 04:06 AM
Joined: Oct 1999
Posts: 71,964
oregon, spr
Marty Offline OP

Marty  Offline OP

There's a very long list of prescription drugs which pharmacies are having a hard time getting unto their shelves after the imposition of strict new labelling standards by the Ministry of Health. And it is having an effect on those who need these products for their everyday health and well being.

The dispute is mostly about a certificate of Good Manufacturing Practice. We told you about this last year, when the Ministry made it a requirement in the law. Because of how international pharmaceutical distribution is structured, this certificate is sometimes difficult or impossible to come by because the manufacturer is not the distributor of the product.

Because of this, Brodies has a shipment of pharmaceutical products imported form Turkey that they say have been stuck at the airport for 9 weeks. They have offered to re-label the products to meet the requirement - but to no avail. The company, which is one of Belize; biggest importers is now considering the possibility that it may have to discard and destroy the drugs.

According to Brodies, if you are taking any of these drugs, "either you will have difficulty in obtaining them, or you will pay a much higher price - if you can source them."

We hope to have a response from the Ministry tomorrow.

Channel 7

Re: Pharma-shortage! [Re: Marty] #532047
08/29/18 06:17 AM
08/29/18 06:17 AM
Joined: Oct 1999
Posts: 71,964
oregon, spr
Marty Offline OP

Marty  Offline OP

Ministry of Health Explains Brodies Blockade

Last night we told you about the complaints from one of Belize's biggest pharmaceutical importers, Brodies. The company has had a shipment of medicines from Turkey stuck at the airport for 9 weeks. They cannot get clearance because they don't have the certificates required under new regulations implemented by the Ministry of Health in November of last year.

Today, we got a response from the Ministry of Health which says that Brodies knew the rules well enough, but didn't do what was required at their end.

Dr. Marvin Manzanero, Director of Health Services
"They have a shipment from 5 different pharmaceutical companies. None of the companies that they had brought in met the requirements which means GMP, CPP, labels need to be in English and Spanish. Notwithstanding that, we managed to give them permission for four out of the five companies under the understanding that they are going to bring in the necessary documentation. That's two, three months ago; they still haven't brought it in. There is one particular company, a distributing company, ZIOTIS and I can mention that company, which it is all products are labelled in Turkish. We said we can't allow this shipment to come in. They were alerted of this from May of this year and we told them what the process was. I think what made it a little more complicated in that particular item is that once they sent us what it is that they were trying to bring into the country, when we did an inspection, a visual inspection of what was happening there on the ground, it didn't match. So the products that they said they were bringing in are not the products that we found when we went there: they had different expiry date, different batch number, different pharmaceutical company. So because we are unable to verify that in point of fact what it is that they are saying that they are bringing in is what they are bringing in and to safeguard people, the health of people, we have said to them we can't allow this to come in. We gave them the option of shipping it back; apparently the company doesn't want it to be returned to them, so Brodies is saying well what do we do. Well, the rule has been there for more than a year; it's not that I am going to bend it back for anybody. And it is applicable to everybody; no single company has been allowed to do that."

"Is there maybe you could maybe make them relabel or repackage the medicine?"

Dr. Marvin Manzanero
"That's only part of it. These are products that don't have a GMP, don't have a CPP, they are not labeled in English and Spanish and the fact is they don't match what they said they were bringing in."

"Is there going to be intervention at the ministerial level? What's the next step in dealing with this?"

Dr. Marvin Manzanero
"Well I think the minister has met with them as well with the owners of Brodies and explained to them what the process was - the reason why we are taking the stance we are taking."

As he noted, Brodies cannot return the shipment to its supplier. We have seen emails where the company asks the Ministry of Health how it is to destroy the medicines.

Channel 7

Re: Pharma-shortage! [Re: Marty] #532065
08/30/18 04:46 AM
08/30/18 04:46 AM
Joined: Oct 1999
Posts: 71,964
oregon, spr
Marty Offline OP

Marty  Offline OP
Brodies Says Its Customers Are “Desperate” for Medicines

For the past two nights we've been reporting on a shipment of medicines that's stuck at customs. Tonight, Brodies, who imported the products from a supplier in Turkey, says it is quote, "faced with the sad realization of having to destroy ninety thousand dollars plus of high quality medications…"

The company sent out a super-rare press release today saying it has been using the Turkish supplier for years, and the medications are from reputable companies like Pfizer, GlaxoSmithKline and Novartis, to name a few. But the labelling is in Turkish, and the new law states they must be labelled in English or Spanish. Brodies says it is willing to re-label the medicines in English or Spanish, but say the Minister is refusing to allow this.

Brodies says they have made every other effort to get the medicines cleared, but to no avail. Now, the company claims, quote, "over the past weeks, many patients, for whom we order special medications from this same company have contacted us DESPERATE for their medication." The release notes that two of the patients - one of whom was a nine year old needed the medication desperately and got special permission for this release from the government.

Still, as you heard the Director of Health Services say yesterday, the Ministry will not budge, so Brodies seems left with little alternative other than to destroy the medicines. Surely, the company hopes that by going public it can create some public pressure to force government's hand. We'll keep following it.

Channel 7

Re: Pharma-shortage! [Re: Marty] #532087
08/31/18 06:01 AM
08/31/18 06:01 AM
Joined: Oct 1999
Posts: 71,964
oregon, spr
Marty Offline OP

Marty  Offline OP

Ministry of Health says Brodies Knew the Rules

The Ministry of Health has responded to James Brodie & Company Ltd.’s press release about a shipment of pharmaceutical products being denied entry into Belize. The Ministry pointed out it informed stakeholders in November 2016 that in 2017 there would be a Statutory Instrument that required labeling and documentation of all pharmaceutical products to be in English and/or Spanish. Of all the companies that imported products in a different language, James Brodie and Company stood alone and continued to import the same products. This includes ZIOTIS which claimed to be coming from England but was from Turkey.

The Ministry said it wrote Brodies on June 21 informing them that any shipment that is on its way will not be allowed into the country unless they have been granted approval prior to its arrival. Brodies proceeded to import the container which showed that all product labels and patient leaflet information were in Turkish; no affixed English or Spanish labels were found. Also noted were changes in names, manufacturer, batch number, and expiry date. There was also a higher quantity than that declared on the invoice for importation. An undeclared product invoice also appeared on the shipment.

There were five shipments on hold since June 2018, however, the Ministry released four based on the company’s compromise that they will be submitting all necessary documentation, of which only one has been received. For the ZIOTIS shipment on hold, the Ministry continued its plea to return to its supplier due to the significant discrepancies, but it is regrettable to note that ZIOTIS could not accept the return even after these were flagged. At no time did Brodies clarify these discrepancies to the Ministry, moreover, provide any proof of authenticity and quality of the products.

The Ministry stresses that No pharmaceutical company has been authorized to re-label or re-package pharmaceuticals that are not in English and/or Spanish. There is also a procedure set in place for patients who wish to import their medication to the country and also for all those patients who bear a rare disease.


Ministry Doubles Down On Blocking Turkish Meds

Brodies has gone public in its war with the Ministry of Health - and tonight, the Ministry is snapping back. The Ministry says that after it implemented new regulations requiring labelling only in English or Spanish for all medicines, it identified five pharmaceutical companies out of 37 that were importing products with labels in other languages. Four of those companies discontinued importation of these foreign language medicines, except for Brodies.

The Ministry says that - in spite of the regs - it has still found foreign language medicines on pharmaceutical shelves supplied by Brodies up to May, 2018.

And then in June 2018, Brodies went to the Ministry with a list of over 160 products that did not have the required english-spanish labels. The Ministry says it did not take any action on these because they were already in the country. Then later that month, Brodies requested importation for a shipment of medicines coming from Turkey, with a receipt from a supplier in England. That told the Ministry that it was not coming from England and this shipment was not granted importation approval.

Still, the Ministry says Brodies brought it in - despite warnings that it would not be allowed into the country. Indeed, when the shipment reached, all product labels and patient leaflet information were in Turkish. The Ministry says it met with Brodies to request that the shipment be returned to its supplier. But the supplier could not accept the return even after the products were flagged.

Brodies now says it will have to destroy the ninety thousand dollars worth of medicines - they say to the detriment of persons who need specific medicines.

The Ministry says there is a procedure set in place for patients who wish to import their medication to the country and also for all those patients who bear a rare disease.

Channel 7

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